FDA Draft Guidance on Expansion Cohorts – Read IDDI Comments
FDA Draft Guidance on the Use of Expansion Cohorts in first-in-human clinical trials
IDDI has submitted a comment on the Food and Drug Administration (FDA) recent Draft Guidance for Industry regarding the use of expansion cohorts in first-in-human clinical trials.
With a scientifically-driven culture, International Drug Development Institute (IDDI) has always been at the forefront of methodological research (over 600 scientific publications). We believe that the most efficient and cost-effective way to design and conduct clinical trials is to make the best possible use of advanced and innovative statistical methodology. We have a particular interest in improving and proposing statistical methods that can make your clinical development more efficient and reliable.